CN111278497A

CN111278497A - Lumen control catheter

Info

Publication number: CN111278497A
Application number: CN201880069855.6A
Authority: CN
Inventors: T·T·泰格; J·J·戴利
Original assignee: St Jude Medical Cardiology Division Inc
Current assignee: St Jude Medical Cardiology Division Inc
Priority date: 2017-11-28
Filing date: 2018-11-28
Publication date: 2020-06-12
Anticipated expiration: 2038-11-28
Also published as: EP3681427B1; JP2021504022A; JP2021504034A; JP2022169702A; JP7130748B2; WO2019108664A3; US20200375657A1; EP4115936B1; EP4327771A3; US11672947B2; EP4115936A1; US20240033470A1; WO2019108661A1; CN111491582A; EP4327771A2; EP3668581A4; CN111491582B; JP7082199B2; CN117942483A; US20230285716A1

Abstract

An elongate medical device, comprising: a first lumen, wherein a cross-sectional shape of the first lumen comprises a peanut shape; and a plurality of second lumens, wherein the plurality of second lumens are adjacent to the first lumen, wherein the first lumen comprises a luminal liner conforming to a cross-sectional shape of the first lumen, wherein the luminal liner comprises a first material and the elongate medical device comprises a second material, wherein the first material is different from the second material.

Description

Lumen control catheter

Cross Reference to Related Applications

This application claims benefit of united states provisional patent application No. 62/591,278 (the '278 application), filed on 28.11.2017, and this application claims benefit of united states provisional patent application No. 62/743,389 (the' 389 application), filed on 09.10.2018. Both the '278 application and the' 389 application are incorporated herein by reference as if fully set forth herein.

Technical Field

The present invention relates to systems and devices for catheter-based cardiac electrophysiology mapping and treatment. In particular, the present invention relates to lumen control in catheters used for mapping and treatment.

Background

Electrophysiology catheters are used in various diagnostic and/or therapeutic medical procedures to correct conditions such as atrial arrhythmia, including, for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Arrhythmias can produce a variety of dangerous conditions, including irregular heart rates, loss of synchronous atrioventricular contractions, and blood flow stasis, all of which can lead to a variety of illnesses and even death.

Typically during a procedure, a catheter is maneuvered through a patient's vasculature to, for example, a patient's heart and carries one or more electrodes that may be used for mapping, ablation, diagnosis, or other treatments and/or treatments. Once at the target site, the treatment may include Radio Frequency (RF) ablation, cryoablation, laser, chemical, high intensity focused ultrasound, and the like. The ablation catheter applies such ablation energy to the cardiac tissue to create a lesion in the cardiac tissue. These lesions interfere with undesired electrical pathways and thereby limit or prevent discrete electrical signals that cause arrhythmia. It is evident that such treatment requires precise control of the catheter during manipulation and at the treatment site, which is consistently dependent on the skill level of the user.

To position the catheter at a desired site within the body, some means of guidance may be used, such as using a mechanical steering feature introduced into the catheter (or introducer). In some embodiments, medical personnel may manually manipulate and/or operate the catheter using mechanical steering features.

To facilitate advancement of the catheter through the vasculature of the patient, a guidance system may be used. Such a guidance system may, for example, comprise an electric-field-based positioning and guidance system that is capable of determining the position and orientation of a catheter (and similar devices) within the body and mapping body features. Various therapeutic means can be delivered through the catheter to tissues with varying shapes and sizes. To better accommodate various sensors and devices for mapping body features at the distal portion of the catheter, assess sufficient contact with the tissue for treatment, and/or provide treatment to the tissue, it is important to have multiple sensors connected to the flex circuit and wires in addition to other lumens inside the catheter. The ability to control the various wires and flexible circuits is necessary to accommodate some sensors having larger cross-sectional shapes (compared to existing catheters) and flexible circuits that couple the sensors with the catheter. It is also desirable to use elements located within the lumen to assist in maintaining the planarity of the catheter as it changes shape during surgery.

The foregoing discussion is intended to be merely illustrative of the art and should not be taken as limiting the scope of the claims.

Disclosure of Invention

In at least one embodiment, the present invention comprises: a first lumen, wherein a cross-sectional shape of the first lumen comprises a peanut shape; and a plurality of second lumens, wherein the plurality of second lumens are proximal to the first lumen, wherein the first lumen comprises a luminal liner conforming to a cross-sectional shape of the first lumen, wherein the luminal liner comprises a first material and the elongate medical device comprises a second material, wherein the first material is different from the second material.

Another embodiment includes a method of forming a luminal liner comprising: inserting one or more cores into the tube; -aligning the tube within a mould assembly, wherein a mould cross-section of the mould assembly corresponds to a cross-section of the lumen lining; compressing the mold assembly around the tube and the one or more cores; heating the mold assembly for a first period of time; cooling the mold assembly for a second period of time; decompressing the mold assembly; removing the lumen liner from the mold assembly; and removing the mandrel from the lumen liner.

Drawings

Fig. 1 is a system block diagram illustrating a medical device and a medical positioning system according to an embodiment of the invention.

FIG. 2 is a plan view of an elongate medical device with a deflectable shaft section according to an embodiment of the invention. Fig. 2 generally illustrates a deflectable electrophysiology catheter.

Fig. 3 is a cross-sectional view of a current catheter design that includes multiple separate lumens for use with the catheter, according to an embodiment of the present invention.

Fig. 4A is a cross-sectional view of a catheter including multiple lumens for use with the catheter, in accordance with an embodiment of the present invention.

Fig. 4B is a cross-sectional view of the luminal liner of fig. 4A in accordance with an embodiment of the present invention.

Fig. 5 is a cross-sectional view of the catheter of fig. 3 showing additional luminal space of this configuration as compared to the luminal space in the catheter of fig. 2, in accordance with an embodiment of the present invention.

Fig. 6A is a cross-sectional view of a catheter with multiple lumens, including multiple wires, according to an embodiment of the present invention.

Fig. 6B is an isometric cross-sectional view of the catheter of fig. 5A containing multiple lumens, including multiple wires, according to an embodiment of the invention.

FIG. 7A is a cross-sectional view of a catheter with multiple lumens, including an actuation wire, according to an embodiment of the present invention.

Fig. 7B is an isometric view of the catheter of fig. 7A including multiple lumens, in accordance with an embodiment of the present invention.

Figures 8A-C illustrate various views of a mold, a lumen liner, and a mandrel for shaping a lumen liner according to embodiments of the present invention.

Fig. 9A-9C illustrate various views of a mold assembly in a decompressed configuration, including the first mold of fig. 8A, in accordance with an embodiment of the present invention.

Fig. 10A-C illustrate various views of the mold assembly of fig. 9A-C in a compacted configuration, in accordance with an embodiment of the present invention.

Fig. 11A-C are isometric views of deflectable segments of a catheter according to embodiments of the invention.

Detailed Description

Referring now to the drawings, in which like numerals refer to the same or similar features throughout the several views. Fig. 1 illustrates one embodiment of a system 10 for guiding a medical device within a body 12. In the illustrated embodiment, the medical device includes a catheter 14, which is schematically shown entering a heart that has been separated from the body 12. The catheter 14 is shown in this embodiment as an irrigated Radio Frequency (RF) ablation catheter for treating cardiac tissue 16 in the body 12. However, it should be understood that system 10 may be used in conjunction with a variety of medical devices for diagnosis or treatment within body 12. For example, the system 10 may be used to guide, for example, an electrophysiology catheter, a mapping catheter, an intracardiac echocardiography (ICE) catheter, or an ablation catheter, using different types of ablation energy (e.g., cryoablation, ultrasound, etc.). Further, it should be understood that the system 10 may be used to guide medical devices for diagnosing or treating portions of the body 12 other than the cardiac tissue 16. Further description of the systems and components is contained in U.S. patent application 13/839,963 filed on 3, 15, 2013, which is incorporated herein by reference as if fully set forth herein.

Still referring to fig. 1, the ablation catheter 14 is connected to a fluid source 18 for delivery of a biocompatible irrigation fluid, such as saline, by a pump 20, which pump 20 may, for example, comprise a fixed rate roller pump or a variable volume syringe pump with gravity feed from the fluid source 18 as shown. The catheter 14 is also electrically connected to an ablation generator 22 for delivering radiofrequency energy. The catheter 14 may include a handle 24; a cable connector or interface 26 at the proximal end of the handle 24; and a shaft 28 having a proximal end 30, a distal end 32, and one or more electrodes 34. The connector 26 provides mechanical, fluid, and electrical connections for tubing or cables extending from the pump 20 and the ablation generator 22. The catheter 14 may also include other conventional components not shown herein, such as a temperature sensor, additional electrodes, and corresponding conductors or wires.

The handle 24 provides a location for the physician to hold the catheter 14 and further provides a tool for steering or guiding the shaft 28 within the body 12. For example, the handle 24 may include such a tool that is capable of varying the length of one or more pull wires extending from the handle 24 through the catheter 14 to the distal end 32 of the shaft 28. The configuration of the handle 24 may vary.

The shaft 28 may be made of conventional materials such as polyurethane and may define one or more lumens configured to receive and/or transport electrical conductors, fluids, or surgical tools. The shaft 28 may be introduced into a vessel or other structure within the body 12 through a conventional introducer. The shaft 28 is then steered or guided through the body 12 to a desired location, such as tissue 16, using a guidewire or pull wire or other means known in the art including a teleguided system. The shaft 28 may also allow for the delivery, and/or removal of fluids (including irrigation fluids and bodily fluids), drugs, and/or surgical tools or instruments. It should be noted that any number of ways of introducing the shaft 28 to a region within the body 12 may be used. This may include an introducer, sheath, guide member, guide wire, or other similar device. For ease of discussion, the term introducer is used throughout.

System 10 may include an electric field-based positioning system 36, a magnetic field-based positioning system 38, a display 40, and an Electronic Control Unit (ECU)42 (e.g., a processor). Each exemplary system component is further described below.

An electric field-based positioning system 36 and a magnetic field-based positioning system 38 are provided for determining the position of the catheter 14 and similar devices within the body 12The position and orientation of (a). The position and orientation of catheter 14 and similar devices within body 12 may be determined by system 36 and/or system 38. The system 36 may include an EnSite, such as sold by sauerda medical limited, saint youdalo, mn, and described in, for example, U.S. patent No. 7,263, 397 entitled "method and apparatus for catheter guidance and location mapping in the heart"^TMNavX^TMThe entire disclosure of this patent is incorporated herein by reference as if fully set forth herein.

Systems

36 and 38 may include, for example, EnSite Precision sold by san Youda medical Co., Ltd, St. Paul, Minn^TMProvided is a system. The system 36 operates on the principle that when a low amplitude electrical signal passes through the chest, the body 12 acts as a voltage divider (or potentiometer or rheostat) so that the electrical potential or field strength measured at one or more electrodes 34 on the catheter 14 can be used to determine the position of the electrodes and thus the position of the catheter 14 relative to a pair of external patch electrodes using ohm's law and the relative position of a reference electrode (e.g., in the coronary sinus).

In the configuration shown in fig. 1, the electric-field based localization system 36 also includes three pairs of patch electrodes 44 provided to generate electrical signals for determining the location of the catheter 14 within a three-dimensional coordinate system 46. The electrodes 44 may also be used to generate electrophysiological data about the tissue 16. To create an axis-specific electric field within the body 12, patch electrodes are placed on opposite surfaces of the body 12 (e.g., the chest and back, the left and right sides of the chest, and the neck and legs), and form generally orthogonal x, y, and z axes. A reference electrode/patch (not shown) is typically placed near the stomach, which provides a reference value and serves as the origin of a coordinate system 46 for the guidance system.

According to the exemplary system 36 as depicted in FIG. 1, the patch electrode includes a right patch 44_X1Left side patch 44_X2Neck patch 44_Y1Leg patch 44_Y2Chest patch 44_Z1And a back patch 44_Z2(ii) a And each patch electrode is connected to a switch 48 (e.g., a multiplexing switch) and a signal generator 50. Patch electrode 44_X1、44_X2Along a first (x) axis; patch electrode 44_Y1、44_Y2Placed along the second (y) axis, patch electrodes 44_Z1、44_Z2Along a third (z) axis. A sinusoidal current is driven through each pair of patch electrodes and voltage measurements are obtained for one or more position sensors associated with catheter 14 (e.g., a ring electrode 34 or a tip electrode located near the distal end 32 of catheter shaft 28). The measured voltage is a function of the distance of the position sensor from the patch electrode. The measured voltage is compared to the potential at the reference electrode and the position of the position sensor within the coordinate system 46 of the guidance system is determined.

Magnetic field-based positioning system 38 employs magnetic fields in this exemplary embodiment to detect the position and orientation of catheter 14 within body 12. The system 38 may include a GMPS system, which is available from MediGuide, inc and is shown and described generally, for example, in U.S. patent No. 7,386,339, entitled "medical imaging and guidance system," the entire disclosure of which is incorporated herein by reference as if fully set forth herein. In such a system, a magnetic field generator 52 having three orthogonally arranged coils (not shown) may be employed to create a magnetic field within the body 12 and to control the strength, orientation and frequency of the magnetic field. The magnetic field generator 52 may be disposed above or below the patient (e.g., below the bed) or at another suitable location. The magnetic field is generated by the coils and current or voltage measurements are obtained from one or more position sensors (not shown) associated with the catheter 14. The measured current or voltage is proportional to the distance of the sensor from the coil, thereby allowing the position of the sensor within the coordinate system 54 of the system 38 to be determined.

A display 40 is provided to communicate information to the physician to assist in diagnosis and treatment. The display 40 may include one or more conventional computer monitors or other display devices. The display 40 may present a Graphical User Interface (GUI) to the physician. The graphical user interface may include various information, including, for example, images of the geometry of the tissue 16, electrophysiological data associated with the tissue 16, graphs illustrating the voltage values of the various electrodes 34 over time, images of the catheter 14 and other medical devices, and related information indicative of the relative positions of the catheter 14 and other devices with the tissue 16.

Electronic control unit 42 provides a method for controlling the operation of the various components of system 10, including catheter 14, ablation generator 22, and magnetic generator 52 of magnetic field-based positioning system 38. The electronic control unit 42 may also provide a means for determining the geometry of the tissue 16, the electrophysiological characteristics of the tissue 16, and the position and orientation of the catheter 14 relative to the tissue 16 and the body 12. The electronic control unit 42 also provides a method for generating display signals for controlling the display 40.

As catheter 14 moves within body 12 and within the electric field generated by electric field-based positioning system 36, the voltage readings from electrodes 34 change, thereby indicating the position of catheter 14 within the electric field and within the coordinate system 46 established by system 36. The ring electrode 34 transmits the position signal to the electronic control unit 42 via a conventional interface (not shown).

FIG. 2 is a plan view of an elongate medical device with a deflectable shaft section according to an embodiment of the invention. Fig. 2 generally illustrates a deflectable electrophysiology catheter 14A that includes a deflectable catheter shaft section 56 and a handle 24A. Deflectable catheter shaft section 56 comprises an elongated body having a distal end 32A and a proximal end 31, wherein proximal end 31 is coupled with a proximal catheter shaft section 58. The handle 24A may also include a port 26A for cabling and/or fluid (see fig. 1 and related discussion for more information). The distal end 32A of the deflectable catheter shaft section 56 may include, for example, an electrode 34A. The distal end 30A of the proximal catheter shaft section 58 is coupled with the handle 24A. Using the handle 24A, the deflectable catheter shaft section 56 may be configured to deflect independently of the proximal catheter shaft section 58. A cross-sectional view of the catheter shaft can be seen in fig. 3 and 4A.

Fig. 3 is a cross-sectional view of a current catheter design that includes multiple separate lumens for use with the catheter, according to an embodiment of the present invention. The catheter 60 may include a plurality of first lumens 62 and a plurality of second lumens 64. The first plurality of lumens 62 may have a first lumen diameter 66 and the second plurality of lumens 64 may have a second lumen diameter 68. In some embodiments, the first lumen diameter 66 is greater than the second lumen diameter 68. The plurality of first lumens 62 and the plurality of second lumens 64 may have a generally circular cross-sectional shape.

Each of the plurality of first lumens 62 may include a luminal liner 70. The conduit 60 may comprise a first material. Luminal liner 70 can comprise a second material that is different than the first material. For example, the first material can be a polyether block amide (e.g.,

) Nylon or other suitable material that is soft and reflowable, and the second material may be polyimide, Polyetheretherketone (PEEK), polycarbonate, or any suitable material that can be "heat set" into a particular shape (i.e., heated, formed into a shape, and then cooled while the material allows the new shape to be maintained). The second material may provide additional properties to the catheter including, for example, additional stiffness (i.e., bending resistance), deflection shape, and flatness control. Luminal liner 70 can fit into each of the plurality of first lumens 62 and can be held in place by friction, adhesion, or other suitable methods.

One or more of the plurality of first lumens 62 may be used to route, for example, fluids, control wires for electrodes, sensors, thermocouples, or other similar components (not shown in fig. 2). The plurality of second lumens 64 may be used to route pull wires (not shown in fig. 2), for example, for deflecting the distal portion of the catheter 60. The diameter of the plurality of first lumens 62 limits the size of components/elements that may be routed from the proximal portion of the catheter 60 to the distal portion of the catheter 60.

Fig. 4A is a cross-sectional view of a catheter including multiple lumens for use with the catheter, in accordance with an embodiment of the present invention. The catheter 80 may include a first lumen 82 and a plurality of second lumens 84. The first lumen 82 may include a luminal liner 86. The cross-sectional shape of the first lumen 62 may be designed to be peanut-shaped as described in more detail below. The plurality of second lumens 84 may have a circular cross-section. Other cross-sectional shapes are also possible, including elliptical, oval, hexagonal, etc., where the two shapes are adjacent to each other by a connecting section.

The cross-sectional shape of the first lumen 82 is configured to fit within a catheter (e.g., a generally circular cross-section) and is positioned between the plurality of second lumens 84 as shown in fig. 3. This cross-sectional shape may maximize the size of the first lumen 82 while still maintaining a sufficient wall thickness around the exterior of the catheter and between adjacent lumens (e.g., the first lumen 82 and the plurality of second lumens 84).

The advantage of the first lumen 82 being symmetrically shaped may include having a larger area (e.g., as compared to having two separate lumens (e.g., as shown in fig. 2)) to route a wire flex circuit or any other element along the length (or even a portion of the length) of the catheter. The symmetry of the first lumen 82 may also provide more desirable bending properties for the distal portion of the catheter. (for additional information see FIG. x and related discussion).

The first lumen 82 may contain one or more tubes (i.e., liners) (not shown in fig. 4; see fig. 6A-B and related discussion for details) to contain (i.e., protect) or contain various elements, such as wires for sensors, interactive elements, or similar devices and/or fluids (e.g., saline) to communicate a distal location to a proximal location on the catheter 80.

Fig. 4B is a cross-sectional view of the luminal liner of fig. 4A in accordance with an embodiment of the present invention. As discussed above, the shape of lumen liner 86 can be designed to be peanut-shaped (e.g., hourglass shape, connected by two adjacent circular areas, dumbbell shape, modified ellipsoid shape with two connected circular areas, "open" number 8, etc.). Other ways of describing the cross-sectional shape of the first lumen 82 include, for example, an oval shape with notches on opposite sides, a shape defined by a mathematical formula such as r 2cos2 θ +4 or other similar formula, two circular regions connected by a narrower waist region, and the like. Some embodiments of the peanut shape can be symmetrical as shown in fig. 4A. Other embodiments of the peanut shape may be asymmetrical (not shown; e.g., one rounded portion may be larger than another).

The cross-sectional shape of the luminal liner 86 can generally be described as a shape having more than three distinct regions, including a first region (i.e., region, portion, shape) and a second region, the first and second regions being connected by a third region, wherein the first and second regions are each larger (e.g., in area, width, and/or length when viewed in cross-sectional view) than the third region. The first and second regions may have the same dimensions (e.g., making the cross-section symmetrical), or the first and second regions may have different dimensions (e.g., making the cross-section asymmetrical). The cross-sectional shape may be the same along a given length or may vary (e.g., with a narrowing/widening zone along the length). These variations may be used, for example, to hold or lock the various elements in place within the lumen formed by the luminal liner.

Fig. 5 is a cross-sectional view of the catheter of fig. 3 showing additional luminal space of this configuration as compared to the luminal space in the catheter of fig. 2, in accordance with an embodiment of the present invention. The first lumen 82 of the catheter 80 may include additional regions 88 (e.g., as compared to having two separate lumens in fig. 2) to route wires, flex circuits, or any other elements along the length (or even a portion) of the catheter, including elements that would not otherwise fit within a lumen having a smaller cross-section (e.g., the plurality of first lumens 62 in fig. 2).

Fig. 5A is a cross-sectional view of a catheter with multiple lumens, including multiple wires, according to an embodiment of the present invention. Catheter 80A may include a first lumen 82A, a lumen liner 86A, one or more flexible circuits 90, a plurality of wires 92, and a plurality of second lumens 84A. In some embodiments, the first lumen 92A may further include an auxiliary lumen 94, the auxiliary lumen 94 having a cross-section smaller than the cross-section of the luminal liner 86. The auxiliary lumen 94 may serve as a path that is separate from the rest of the first lumen 84. For example, the auxiliary lumen 94 may be used to transport fluid from the proximal portion of the catheter 80 to the distal portion of the catheter 80.

The catheter 80A may have a lumen defined by line A₁-A₂The indicated deflection plane. The deflection plane represents the direction in which the catheter can bend (e.g., deflect). For example, the user may cause the distal portion of catheter 80A to follow line a (e.g., with a pull wire or other control mechanism)₁-A₂In A₁In the direction of or A₂Deflecting in direction (or in, for exampleWhen the end of the conduit is bent into an "S" shape, i.e. at A₁The direction is also at A₂Deflected in the direction). Additionally, the shape of the elements (e.g., flex circuit 90) within the first lumen 82A may be configured to facilitate following the bending plane a₁-A₂I.e., to provide in-plane bending support. For example, the flexible circuit 90 may have a flexible plane B1-B2 represented by lines as shown in FIG. 5A. The flexible circuit 90 may preferentially follow the flexible plane B₁-B₂Deflecting (e.g. in a plane A with the deflection)₁-A₂In the same direction).

Luminal liner 86A can also facilitate following curved plane a₁-A₂Bending of (2). The bending support provided by luminal liner 86A and/or flexible circuit 90 can help make the bending characteristics of the distal end of the catheter more predictable and consistent. The conduit remaining in the plane of bending A₁-A₂The ability to be within (i.e., maintain planarity) or as close to that plane as possible is desirable for the user because it allows for more precise and low movement and/or manipulation of the catheter during surgery.

In some embodiments (not shown), the flexible circuit 90 may be sized/shaped such that a portion of the flexible circuit couples with a portion of an additional region of the luminal liner (e.g., the additional region of fig. 5). This may allow the position of the flex circuit 90 to be fixed (i.e., "locked") similar to fitting a key into a keyway. Locking the flexible circuit 90 in place facilitates the bending characteristics of the deflectable portion of the catheter. As described herein, the flexible circuit 90 may be predisposed to more easily bend in a particular direction (i.e., along a plane of bending; see FIGS. 11A-C and related discussion for more information). Fixing the position of the flexible circuit may minimize and/or eliminate any movement of the flexible circuit 90 (e.g., jolts, variations, etc. out of the plane of the bend) that may allow for changes in the direction of the preset bend of the flexible circuit when a bending moment is applied to the deflectable portion of the distal end of the catheter (see fig. 11A-C and related discussion for more information).

A plurality of wires 92 may be used to transmit signals to and from a plurality of sensors, electrodes, thermocouples, and other similar elements located at the distal portion of catheter 80A and the proximal portion of the catheter (e.g., to ablation generator 22, electronic control unit 42, and magnetic field generator 52 of fig. 1). Each of the wires of the plurality of wires 92 may be electrically coupled to: various electrodes (e.g., point electrodes, ring electrodes, tip electrodes, etc.), sensors (magnetic position sensors, fiber optic sensor fibers, force sensors, strain gauges, strain sensors, biosensors (e.g., sensors capable of converting a biological response into an electrical signal), diagnostic sensors, therapeutic sensors, chemical sensors (e.g., sensors capable of delivering and/or monitoring drugs/chemicals, etc.), luminescence sensors, acoustic sensors, thermoelectric elements), thermocouples, and other similar devices.

Fig. 6B is an isometric cross-sectional view of the catheter of fig. 6A including multiple lumens, including multiple wires, in accordance with an embodiment of the present invention. Catheter 80A may also have a guidewire C₂-C₂The indicated reinforcement plane. One or more elements (e.g., flexible circuit 90) located within first lumen 82A may be shaped to be prevented from following reinforcement plane C₁-C₂Bending of (2). The resistance to bending may result from, for example, the shape and/or structure of the elements and the materials used in the elements. Along the reinforcement plane C, similar to the above-mentioned curved supports₁-C₂May also facilitate and/or assist the conduit 80A in the bending plane a₁-A₂And (4) bending. For example, catheter 80A may be configured to preferentially follow curved plane A when deflected by a user (e.g., using a pull wire or other similar mechanism)₁-A₂Is bent to follow the plane of reinforcement C₁-C₂Unbent/minimally bent.

FIG. 7A is a cross-sectional view of a catheter with multiple lumens, including an actuation wire, according to an embodiment of the present invention. Catheter 80B may include a first lumen 82B, a luminal liner 86B, an actuation wire 96, a compression spring 98, and a plurality of second lumens 84B.

The compression spring 98 may prevent compression of the deflectable section of the distal portion of the catheter 80B. The compression spring 98 may also ensure that motion from the actuation wire 96 is transferred to a desired section of the catheter (e.g., a variable loop section in a deflectable section of the distal portion of the catheter 80B). The actuation wire 96 may be used to change the loop size/radius of curvature of the deflectable portion of the distal portion of the catheter 80B. The actuation wire 96 may also facilitate movement (i.e., building a second conduit within the main device, such as assisting movement).

Fig. 7B is an isometric view of the catheter of fig. 7A including multiple lumens, in accordance with an embodiment of the present invention. Similar to fig. 7A, fig. 7B shows a catheter 80C with a first lumen 82B, a luminal liner 86B, a third lumen 100, and a plurality of second lumens 84C. In some embodiments, the third lumen 100 may be aligned with a central longitudinal axis of the catheter 80C and may be used, for example, to convey fluid along the length of the catheter 80B (e.g., a closed loop irrigation return path (e.g., where fluid is supplied through the auxiliary lumen 94 (shown in fig. 6A-B) and removed through the third lumen 100), an auxiliary irrigation path where the third lumen 100 is used with a second fluid supply (e.g., a fluid source separate from the fluid source 18 shown in fig. 1. the third lumen 100 may also be used to supply fluid for applications requiring lower flow rates (e.g., as compared to applications requiring larger diameter lumens, such as the auxiliary lumen 94 in fig. 6A-B), and/or to allow additional space for other elements in the lumen liner 86B. in some embodiments, the third lumen 100 may be used to route elements from a proximal portion of the catheter to a distal portion of the catheter, such elements include, for example, wires (e.g., high voltage wires), vacuum, gas/liquid delivery (e.g., for cryotherapy, drugs, etc.), fiber optic(s), guide wires, catheters, endoscopes, Optical Coherence Tomography (OCT) fibers, or other similar devices that a user may desire to use.

Figures 8A-C illustrate various views of a mold, a lumen liner, and a mandrel for molding a lumen liner according to embodiments of the present invention. Fig. 8A is an isometric view of a mold for molding a luminal liner. A portion of mold assembly 110 may include a first mold cavity 112, wherein mold 110 may be used to form a lumen liner 114. The mold may be any suitable material (e.g., aluminum) that may be sized to form a luminal liner 114 of a desired length and shape. The mold 110 may be configured to be heated and used to compact the material and heat set the particular shaped luminal liner 114 (e.g., to form a shape corresponding to the cross-sectional shape of the first lumen 82 in fig. 4).

The method of forming the luminal liner 114 can include the following steps. First, two circular cores made of a suitable material (e.g., metal) may be inserted into a tube having a first shape (e.g., circular or oval). After insertion, the two cores may contact each other and each core may contact a portion of the tube. Second, the assembly with the tube and core may be placed into the first mold cavity 112 and positioned as shown in FIG. 8B. The first mold cavity 112 may be contoured to correspond to a portion (e.g., half) of the desired cross-sectional shape of the lumen liner cross-section.

Figure 8B is a partial isometric view of a mold for forming the lumen liner of figure 8A in accordance with an embodiment of the present invention. Fig. 8A shows an enlarged view of lumen liner 114 with two cores 116 inserted into lumen liner 114, lumen liner 114 and cores 116 positioned over first mold cavity 112.

Figure 8C is a partial end view of the lumen liner of figures 8A-B, two cores, in accordance with an embodiment of the present invention. Two cores 116 are located in the cavity liner 114, and the cavity liner 114 and the cores 116 are located on the first mold cavity 112. As shown, lumen liner 114 and core 116 may be centered over first mold cavity 112.

Fig. 9A-9C illustrate various views of a mold assembly in a decompressed configuration, including the first mold cavity of fig. 8A, in accordance with an embodiment of the present invention. Fig. 9A is an isometric view of mold assembly 110 prior to molding a lumen liner according to an embodiment of the present invention, including first mold cavity 112 and second mold cavity 118. First mold cavity 112 and second mold cavity 118 may be configured to be coupled together to facilitate molding (i.e., shaping) luminal liner 114 into a second shape.

Fig. 9B is a partial isometric view of a mold assembly with the lumen liner and mandrel of fig. 9A prior to molding the lumen liner according to an embodiment of the present invention. Prior to molding, mold assembly 110 is positioned with first cavity 112 and second cavity 118, and core 116 inside of lumen liner 114.

Figure 9C is a partial end view of the first mold cavity, the second mold cavity, and a lumen liner with the core of figures 9A-B according to an embodiment of the present invention. As described herein, when the first and

second mold cavities

112, 118 are compressed together (shown by arrows 120) and heated, the shapes of the first and

second mold cavities

112, 118 may be designed such that the luminal lining matches the shapes of the first and

second mold cavities

112, 118. The third step of forming the luminal liner 114 comprises coupling the first mold cavity 112 and the second mold cavity 118 and compressing and heating the luminal liner 114 to allow it to take the shape of the mold. After the mold is cooled and the cavity liner 114 has the cross-sectional shape of the first mold cavity 112 and the second mold cavity 118, the mold assembly 110 may be opened and the core 116 may be removed from the cavity liner 114 to form the desired cross-sectional shape (i.e., the second shape).

Additional steps may be taken to line the lumen liner 114 to add another layer to the outer surface of the lumen liner 114. A reflowable outer layer (not shown) may be added to the luminal liner 114. The reflowable outer layer may assist in the coupling between the luminal liner 114 and a catheter (e.g., catheter 80A of fig. 6A-B).

Fig. 10A-C illustrate various views of the mold assembly of fig. 9A-C in a compacted configuration in accordance with an embodiment of the present invention. Fig. 10A is an isometric view of the mold assembly of fig. 9A after molding, including a lumen liner and a mandrel, according to an embodiment of the invention. A fourth step may be to cool the mold to room temperature to allow luminal liner 114 to solidify into a shape that conforms to (i.e., matches) first mold cavity 112 and second mold cavity 118. After the mold assembly is cooled, the cross-sectional shape of the lumen liner 114 will correspond to the internal cross-sectional shape of the mold assembly 110, which may correspond to the interior of a catheter (e.g., the first lumen 82 of the catheter 80 of fig. 4).

Fig. 10B is a partial isometric view of the first mold cavity and the second mold cavity in a compacted configuration with a lumen liner and a core according to an embodiment of the invention. As shown in fig. 10A, lumen liner 114, when heated and compressed between first mold cavity 112 and second mold cavity 118, now conforms in cross-sectional shape to the cross-sectional shape of first mold cavity 112 and second mold cavity 118, which may correspond to the interior of a catheter as described herein.

Fig. 10C is a partial end view of the first mold cavity and the second mold cavity in a compacted configuration with a cavity liner and a core, according to an embodiment of the invention. After undergoing the molding process described herein, lumen liner 114 conforms in cross-sectional shape to the shape of first mold cavity 112 and second mold cavity 118, where the cores are separated, creating additional space (e.g., additional region 88 of fig. 5) to create a larger lumen as compared to two adjacent circular lumens that are separated (e.g., first plurality of lumens 62 in fig. 3).

An alternative method of molding the luminal liner (not shown) may involve the use of a single mandrel shaped to match the desired luminal liner volume. For example, a metal rod (i.e., a metal structure) may be shaped to match the cross-sectional shape of the luminal liner 82 of fig. 4. The metal structure may then have a polymer (e.g., polyimide) applied thereto and then allowed to cool. Application of the polymer may be accomplished using any suitable method (e.g., immersion in a reservoir, deposition, spraying, etc.). After the layer of polymer cools, the metal structure may be dipped into the liquid polymer and cooled multiple times, with another layer of polymer being added for each dip/cool cycle. The number of immersions can be controlled to achieve a desired thickness of the luminal lining. After the desired thickness of the lumen lining is obtained, the metal structure may be removed. This approach has the advantage of saving potential costs by eliminating the auxiliary heat-setting (i.e., molding) process described above.

Another alternative method of obtaining a desired shape of a luminal liner is to utilize a heated circular forming tool (not shown) having a similar cross-sectional shape to the mold assembly 110 discussed herein and shown in fig. 8A-10C. The initial lumen liner (e.g., circular or oval in cross-section) will be routed through a series of forming wheels while being heated and then cooled. This approach potentially allows for longer lumen liner sections to be formed in one go, resulting in faster processing times and lower overall product costs.

Fig. 11A-C are isometric views of deflectable segments of a catheter according to embodiments of the invention. Fig. 11A shows catheter 130 in an undeflected state. A distal deflectable catheter shaft portion 56B, which is a substantially tubular structure, extends between the distal end of the catheter shaft 28A and, for example, a tip electrode 132. To deflect the distal deflectable portion 56B, pull

wires

134A and 134B extend from handle 24/24A (in fig. 1/2) through shaft 28A (see also shaft 28 in fig. 1) and attach to pull ring 136.

Fig. 11B shows the catheter 130 of fig. 11A with the deflectable shaft portion, shaft, and electrodes removed for illustration. Upon deflection by an actuator, such as a steering handle (e.g., handle 24 of fig. 1 or handle 24A of fig. 2), pull wires 134A-B produce an eccentric pull on pull ring 136, which exerts a bending moment M on deflectable catheter shaft portion 56B. This deflects a portion of the deflectable catheter shaft portion 56B, thereby allowing the distal tip of the catheter to be positioned relative to the interior region of interest, as shown in fig. 11C.

More specifically, as shown in fig. 11C, the distal tip of the catheter (e.g., tip electrode 132) is moved within a curved plane (i.e., scan plane) 200. As discussed herein, it may be desirable for the deflection of the distal tip to be constrained to lie only within the plane of curvature 200. Such constraint of the desired plane of bending (i.e., maintaining planarity, etc.) may provide consistent and predictable displacement between deflections of the catheter. The position of the puller wires 134A-B may cause the distal tip of the catheter to move within the bending plane 200.

To ensure scanning planarity and consistency of the distal deflectable catheter shaft portion, the pull wire must be nearly perfectly aligned with the prescribed scan plane 200, as shown in fig. 11B. As described above, the various elements of the catheter may also allow for bending along the scan plane 200 (e.g., the flex circuit 90 of FIGS. 6A-6B).

As shown in fig. 11C, plane 210 is perpendicular to scan plane 200. The physical configuration of the conduit may be such that it prevents bending in the direction of plane 200. For example, as described above, the puller wires 134A-B may be aligned with the scan plane 200, and the flex circuit 90 (of fig. 6A-B) may be aligned to bend along the scan plane 200 and resist bending along the plane 210 due to the shape/cross-section of the flex circuit (see discussion above).

Additional information regarding the bending plane and planarity of the deflectable segment of the distal end of the catheter can be found in U.S. patent No. 7,985,215, assigned to the division of medical atrial fibrillation, san yuda, filed 7/26/2011, which is incorporated herein by reference in its entirety as if fully set forth herein.

Although at least one embodiment of an apparatus for detecting a catheter leading to an introducer has been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. Likewise, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is to be understood that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

Embodiments described herein have various apparatuses, systems, and/or methods. Numerous specific details are set forth in order to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described in the specification and illustrated in the accompanying drawings. However, it will be understood by those skilled in the art that the embodiments may be practiced without these specific details. In other instances, well-known operations, components and elements have not been described in detail so as not to obscure the embodiments described in the specification. It will be understood by those of skill in the art that the embodiments described and illustrated herein are non-limiting examples, and thus it is to be understood that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of all embodiments, which is defined by the claims appended hereto.

Reference throughout the specification to "various embodiments," "some embodiments," "one embodiment," or "an embodiment," etc., means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in various embodiments," "in some embodiments," "in one embodiment," or "in an embodiment," or the like, throughout this specification do not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, a particular feature, structure, or characteristic illustrated or described in connection with one embodiment may be combined in whole or in part with features or characteristics of one or more other embodiments without limitation, if such combination is not illogical or functional.

It should be understood that the terms "proximal" and "distal" may be used throughout the specification by reference to an end of the instrument being manipulated by the clinician for treatment of a patient. The term "proximal" refers to the portion of the instrument closest to the clinician and the term "distal" refers to the portion furthest from the clinician. It will be further appreciated that spatial terms such as "vertical," "horizontal," "up," "down," and the like may be used herein with respect to the illustrated embodiments for purposes of brevity and clarity. However, medical devices may be used in many orientations and positions, and this term is not intended to be limiting and absolute.

Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, to the extent that the disclosure is explicitly set forth herein, this disclosure supersedes any conflicting material incorporated herein by reference. It is said that any material, or portion thereof, that is said to be incorporated by reference herein, in such an extent as to contradict existing definitions, statements, or other disclosure material set forth herein, is intended to be incorporated only to the extent that no conflict exists between that incorporated material and the existing disclosure material.

Claims

1. An elongate medical device, comprising:

a first lumen, wherein a cross-sectional shape of the first lumen comprises a peanut shape; and

a plurality of second lumens, wherein the plurality of second lumens are adjacent to the first lumen,

wherein the first lumen comprises a luminal liner conforming to a cross-sectional shape of the first lumen, wherein the luminal liner comprises a first material and the elongate medical device comprises a second material, wherein the first material is different from the second material.

2. The elongate medical device of claim 1, wherein said peanut shape is symmetrical.

3. The elongate medical device of claim 1, wherein said peanut shape is asymmetric.

4. The elongate medical device of claim 1, wherein said luminal liner is a first material and said elongate medical device comprises a second material, wherein said first material is different than said second material.

5. The elongate medical device of claim 4, wherein said first material is a heat-settable polymer and said second material is a reflowable polymer.

6. The elongate medical device of claim 1, wherein said plurality of second lumens are configured to accommodate a pull wire.

7. The elongate medical device of claim 6, wherein said plurality of second lumens each comprise a circular cross-section.

8. The elongate medical device of claim 1, wherein said first lumen further comprises a third lumen, wherein said third lumen comprises a circular cross-section.

9. The elongate medical device of claim 1, wherein said first lumen is located between said plurality of second lumens.

10. The elongate medical device of claim 1, wherein said luminal liner further comprises an outer layer.

11. The elongate medical device of claim 10, wherein said outer layer is a reflowable material.

12. A method of forming a luminal liner comprising:

inserting one or more cores into the tube;

aligning the tube within a mold assembly, wherein a mold cross-section of the mold assembly corresponds to a lumen liner cross-section;

compressing the mold assembly around the tube and the one or more cores;

heating the mold assembly for a first period of time;

cooling the mold assembly for a second period of time;

decompressing the mold assembly;

removing the lumen liner from the mold assembly; and

removing the core from the lumen liner.

13. The method of claim 12, wherein the mold cross-section is peanut-shaped.

14. The method of claim 13, wherein the peanut shape is symmetrical.

15. The method of claim 13, wherein the peanut shape is asymmetric.

16. The method of claim 12, wherein the luminal liner is a first material and the elongate medical device comprises a second material, the first material being different than the second material.

17. The method of claim 16, wherein the first material is a heat-set polymer and the second material is a reflowable polymer.

18. The method of claim 12, further comprising adding an outer layer to the luminal liner.

19. The method of claim 13, wherein the outer layer is a reflowable material.